4 ms·

This is a little sensationalist - it's a list of deficiencies in their labs, not in their tests. More akin to an OSHA violation letter than a cease and desist l

This is a little sensationalist - it's a list of deficiencies in their labs, not in their tests. More akin to an OSHA violation letter than a cease and desist letter. Here is an example of the regs that they are violating. It's things like lack of lab personnel certification. https://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5-sec493-1441.pdf https://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-... This is definitely not a good thing for Theranos, but it isn't them being called out for bogus biotech. (Not that that would surprise me immensely if it happened.)

URSpider94 11y ago
No, it's worse -- this is basic blocking and tackling stuff that is table stakes for entering the medical testing space. This is not stuff that you "disrupt." As the letter says, these deficiencies could be putting customers' lives at risk.
Aleman360 11y ago
That's exactly what the FDA does for medical devices. They don't test devices, they audit your facilities, processes, and product documentation.
timr 11y ago
It's only "sensationalist" if you cherry-pick the most bureaucratic-sounding requirement, and ignore the first one in the list, which is a lot more fundamental to what a diagnostic lab does -- they're violating some unspecified part(s) of the quality system requirements for labs: https://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5-sec493-1215.pdf https://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-... These are horribly oppressive, bureaucratic, unnecessary requirements like "maintain basic scientific controls": https://www.law.cornell.edu/cfr/text/42/493.1256 https://www.law.cornell.edu/cfr/text/42/493.1256 This also is a section, it's worth nothing, that consists mainly of references to lots of other, more specific, requirements. There's really no way of knowing what the violations are, other than to take the letter at its word that the violations are serious. This isn't taxi medallions -- mess this basic stuff up, and you're putting people's lives directly at risk.
- pboutros 11y ago
  I only randomly picked a CFR to look up. This is totally a big deal! It just isn't the definitive 'none of these tests work' that many people have been expecting.
  - akiselev 11y ago
    When it comes to biotech companies working in clinical diagnostics, lacking the proper credentials is way WORSE than 'none of these tests work.' Most diagnostics companies self regulate by hiring an FDA certified lab managers and technicians who share responsibility for making sure that the marketed product, in this case blood tests, is properly carried out and that it is comparable to the gold standard (usually much more expensive tests with known performance and false negative/positive rates). The FDA set it up this way because otherwise regulating all of the labs and their output like pharmaceuticals would be insanely more expensive and wildly impractical. A company like Theranos selling blood tests without properly certified staff is the equivalent of Genentech or Pfizer marketing and selling snake oil disguised as cancer medication. It's the equivalent of selling something without having ever tested it to begin with.
    - quotefoundslash 11y ago
      This happened: http://www.reuters.com/article/us-roche-europe-idUSBRE85K1NH20120621 http://www.reuters.com/article/us-roche-europe-idUSBRE85K1NH...

URSpider94 11y ago

No, it's worse -- this is basic blocking and tackling stuff that is table stakes for entering the medical testing space. This is not stuff that you "disrupt." As the letter says, these deficiencies could be putting customers' lives at risk.

Aleman360 11y ago

That's exactly what the FDA does for medical devices. They don't test devices, they audit your facilities, processes, and product documentation.

timr 11y ago

It's only "sensationalist" if you cherry-pick the most bureaucratic-sounding requirement, and ignore the first one in the list, which is a lot more fundamental to what a diagnostic lab does -- they're violating some unspecified part(s) of the quality system requirements for labs: https://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5-sec493-1215.pdf https://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-... These are horribly oppressive, bureaucratic, unnecessary requirements like "maintain basic scientific controls": https://www.law.cornell.edu/cfr/text/42/493.1256 https://www.law.cornell.edu/cfr/text/42/493.1256 This also is a section, it's worth nothing, that consists mainly of references to lots of other, more specific, requirements. There's really no way of knowing what the violations are, other than to take the letter at its word that the violations are serious. This isn't taxi medallions -- mess this basic stuff up, and you're putting people's lives directly at risk.

pboutros 11y ago
I only randomly picked a CFR to look up. This is totally a big deal! It just isn't the definitive 'none of these tests work' that many people have been expecting.
- akiselev 11y ago
  When it comes to biotech companies working in clinical diagnostics, lacking the proper credentials is way WORSE than 'none of these tests work.' Most diagnostics companies self regulate by hiring an FDA certified lab managers and technicians who share responsibility for making sure that the marketed product, in this case blood tests, is properly carried out and that it is comparable to the gold standard (usually much more expensive tests with known performance and false negative/positive rates). The FDA set it up this way because otherwise regulating all of the labs and their output like pharmaceuticals would be insanely more expensive and wildly impractical. A company like Theranos selling blood tests without properly certified staff is the equivalent of Genentech or Pfizer marketing and selling snake oil disguised as cancer medication. It's the equivalent of selling something without having ever tested it to begin with.
  - quotefoundslash 11y ago
    This happened: http://www.reuters.com/article/us-roche-europe-idUSBRE85K1NH20120621 http://www.reuters.com/article/us-roche-europe-idUSBRE85K1NH...